[Pharma Digests]

ICH E6 (R3) Guideline on good clinical practice (GCP)

[Pharma Digests]

Critical process parameters for Lyophilized Product Development:
– Freezing temperature
– Primary drying temperature
– Secondary drying temperature
– Time for annealing
– Pressure and time

[Pharma Digests]

Fundamental tests for pharmaceutical finished products:
– Identification
– Assay
– Dissolution
– CU/WV
– Impurity

[Pharma Digests]

Few critical check points for pharmaceutical manufacturing facilities to face FDA GMP audit:
– SOPs are up-to-date with practice
– Deviations and CAPAs
– Previous audit observations
– Data integrity
– Cleaning validation

[Pharma Digests]

To apply to market a new drug, biologic, or an antibiotic drug for human use (including NDA & ANDA), firstly you need to complete Form 356h.

Form 356h include: submission date, applicant information, product description, NDA/ANDA application number etc.

After successful filing your product, FDA will conduct application based GMP inspections to ensure the facility is capable of manufacturing the product consistently and that submitted data are accurate and complete.

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